FDA Adverse Event
Malfunction
Summary report: N
9616240-2008-00020
MDR report key: 1031524
·
Received March 31, 2008
Report
- Report Number
- 9616240-2008-00020
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Product Code
- KDI
- PMA / PMN Number
- K001156
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTORS HAVE BEEN APPROVED BY GAMBRO DASCO AND WILL BE IMPLEMENTED IN THE FIELD. THIS EVENT IS BEING REPORTED AS "MALFUNCTION" UNDER THE MDR 2-YR RULE, REGARDLESS OF ANY PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KDI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |